You can report defective medicines or medicines suspected of being falsified to the Icelandic Medicines Agency by emailing lyfjastofnun@lyfjastofnun.is.

Information required in a report

The following information should be included wherever possible:

• Name of the medicine

• Strength

• Batch number

• Expiry date

• Product number

• A clear description of the defect

• Photographs or a sample of the medicine

Additional information

Reports submitted by manufacturers, marketing authorisation holders or wholesalers must include the following:

• All basic information about the medicine (name, strength, batch number, expiry date, etc.)

• A detailed description of the defect and information on preventive measures

• Details of the manufacturer, marketing authorisation holder and wholesaler (distributor) in Iceland, as well as the representative, where applicable

• Information on stock levels and distribution of the medicine in Iceland

• Information on parallel importation into Iceland

• The extent / frequency of the defect

• A risk assessment of the defect, where possible

• Proposed market actions, including how far along the distribution chain they should extend (to wholesalers, pharmacies or patients)

Reporting deadlines

How are reports processed?

Experts at the Icelandic Medicines Agency assess reports of defective or falsified medicines with a focus on patient safety. If necessary, a medicine may be recalled in cooperation with the companies involved, usually the marketing authorisation holder. The assessment takes into account any medicine shortages or distribution difficulties that the proposed actions could cause, and their potential impact on patients.

Information about defective or falsified medicines may be submitted by:

• Pharmaceutical companies (manufacturers, marketing authorisation holders or wholesalers)

• Medicines regulatory authorities in other countries, which share information through the rapid alert network

• Pharmacies

• Healthcare professionals

• People who use medicines

Reports from healthcare professionals and people who use medicines are forwarded to the marketing authorisation holder for investigation.

The severity of the defect or falsification is assessed against several criteria, and the case is assigned to one of three risk categories:

Class 1: Use of the defective or falsified medicine could be life-threatening or pose a serious health risk.

Class 2: Use of the medicine may cause illness or lead to incorrect treatment.

Class 3: The defective or falsified medicine is unlikely to pose a serious health risk, but suspension of sales or a recall may still be considered for other reasons.

How is a recall carried out?

If an investigation identifies a serious defect or deviation in a medicine that is on the market in Iceland or exported from Iceland, the affected batch or batches may be recalled.

The pharmaceutical company (e.g. the marketing authorisation holder, manufacturer or wholesaler) must notify the Icelandic Medicines Agency in advance of any planned recall. Once the decision to recall the medicine has been made, the company must send a recall letter to the Icelandic Medicines Agency before formally notifying the parties concerned. This is in accordance with European good practice standards and national laws and regulations.

The Icelandic Medicines Agency assesses the proposed actions based on the information provided, taking into account any medicine shortages or distribution difficulties that the actions could cause. It also assesses whether medicines regulatory authorities in other countries need to be informed. If so, the information is shared through the rapid alert network.

The Icelandic Medicines Agency may ask the pharmaceutical company concerned to provide a report on how the recall was carried out.